Trial Outcomes & Findings for Ketamine in Chronic Kid's (KiCK) Pain (NCT NCT01755169)
NCT ID: NCT01755169
Last Updated: 2017-01-23
Results Overview
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2 weeks
Results posted on
2017-01-23
Participant Flow
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Participant milestones
| Measure |
Ketamine 0.25 mg/kg/Dose
A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 0.5 mg/kg/Dose
A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 1 mg/kg/Dose
A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine in Chronic Kid's (KiCK) Pain
Baseline characteristics by cohort
| Measure |
Ketamine 0.25 mg/kg/Dose
n=2 Participants
A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 0.5 mg/kg/Dose
n=1 Participants
A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 1 mg/kg/Dose
A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Placebo
n=1 Participants
Placebo
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
8-20 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Gender
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
—
|
1 participants
n=7 Participants
|
4 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 weeksA total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Outcome measures
| Measure |
Ketamine 0.25 mg/kg/Dose
n=2 Participants
A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 0.5 mg/kg/Dose
n=1 Participants
A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Ketamine 1 mg/kg/Dose
A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
|
Placebo
n=1 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ketamine 0.25 mg/kg/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine 0.5 mg/kg/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine 1 mg/kg/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place